These qualitative interviews explore the influence of patents on practice at a ‘micro’ level, that is, how patents and beliefs about patents influence the practice of those who are actually involved in translational research. The focus of this research is on the behaviour and motivations of individuals, but it also investigated the institutional and cultural context which underlies that behaviour. Interviewees were selected on the basis of their role in the four phases of translation in NIPT and included senior researchers; legal counsel and managers of commercial testing providers; laboratory managers; clinical geneticists and obstetricians; technology transfer professionals; and health service managers. Interviews sought to elicit day-to-day practice as well as exploring motivations and reasons for particular behaviour and interviews were conducted according to an interview schedule which covered core areas for all interviews, and areas specific to the profession of the expert interviewee. Interviews were transcribed by a professional transcriber.Patent law is the first area of law that comes into contact with new innovation, because patents are the main means by which the state incentivises innovation. In return for disclosure of an invention, the state grants a monopoly to the patent holder. Whilst patents may work as intended to provide that incentive to innovation, patents may also work against the public interest by reducing public access to technology, or by shaping the development of technology in inappropriate ways. The intersection of patent law with modern innovation such as genomics poses particular challenges, and the traditional principles of law are being strained almost to breaking point by patents claiming the very building blocks of life itself. Despite the publicly funded nature of this research, technologies in this area, and many genes themselves, are the subject of patent rights, and the patent owner has the potential to control the development of, and access to, the technology in question. At the same time, medicine is failing to accommodate patent rules, and there is divergence between law and practice. Through the Human Genome Project and continuing research, we now have the most detailed map to date of the information programmed in our DNA - the information that makes us who we are. DNA abnormalities can lead to many common conditions such as Down's Syndrome and Cystic Fibrosis, and we are currently able to diagnose these conditions in adults by genetic tests, or in unborn children by testing foetal tissue. Soon, we will be able to diagnose disorders, and decipher a baby's entire genetic make-up by the simple procedure of analysing a sample of blood from a pregnant woman; a process called Non-Invasive Prenatal Diagnosis (NIPD), which will revolutionise the clinical management of pregnancy worldwide. Understanding how patents in this field in Britain, Europe and the USA are enforced, and how companies, healthcare organisations and individuals interact with the system, is important to facilitate the development of, and public access to, NIPD. Perhaps more importantly, this research, and previous work of the PI investigating patents in single gene testing will be used as case studies to explore the wider issues surrounding the translation of innovations in genomic medicine into clinical practice. How patent law operates in practice has implications for delivery of technologies to the public, how companies and researchers innovate, how individuals decide to act, and how healthcare evolves in the face of emerging research that promises to change the face of medicine. The research will further make an important contribution to patent law scholarship, by an empirically informed conceptualisation of the role of patents in practice in frontier technologies. The applicant has extensive experience in the legal issues surrounding genomic medicine. She will employ and develop socio-legal research methods to develop a theory of the role that patents play in emerging fields of genomic medicine, and foster improved international awareness and discussion of the subject. She will interview the leading international players in the field, as well as investigating the relationships between them through social network analysis. The analysis will be used to tease out how an appreciation of patents shapes day-to-day practice and future direction in translational research in NIPD. This work is necessary to protect the interests of the public without impinging on innovation in the private sector. This project investigates an emerging and relatively young aspect of law which is set to become much more important as genomic medicine becomes a routine part of medical practice and as other frontier technologies challenge patent law in practice. Little legal work has been done in the area - this project will strengthen the applicant's position as a future leader in the field.

The data in this collection arises from a qualitative interview study conducted with stakeholders in the translational research process in NIPT in Europe. Participants were recruited from three groups; genetics laboratory staff and management, commercial NIPT providers and researchers and clinicians, although there was some overlap between these categories. The study focused primarily on those working in, or interacting with, the public sector in Europe. Targeted sampling was employed, to ensure an appropriate spread of interviewees. The sample was approximately two thirds constituted by public laboratory senior staff and directors (many of whom were also research active), with the remaining one third being clinicians (also mostly research active) and those working in a commercial context. The majority of interviewees were based in Europe, although some were previously based in Europe and had relocated to other countries. Interviewees were recruited through approaches by the author at scientific conferences, email contact and through personal recommendation of those working in the field. A final method of identification of potential interviewees was through ‘snowball sampling’. At the end of each interview, an interviewee was asked to identify other individuals whom he or she thought would be suitable for the candidate to interview. This method identified a small number of additional interviewees. Forty interviews of approximately one hour each were conducted (25 between July 2014 and April 2015; 15 between April 2016 and August 2017). The interviews were conducted face-to-face or by telephone. Interviews were recorded on a digital voice recorder and professionally transcribed, and analysed using grounded theory methodology, using NVivo. The interviews were conducted as semi-structured qualitative interviews, and the topics were addressed in roughly the same order, but in differing degrees of detail, depending on the interests and expertise of the interviewees.